BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTON DEAN SI-1000

    MDR report key: 35993 · Received August 19, 1996

    Report

    Report Number
    1720804-1996-09001
    Event Type
    Malfunction
    Date Received
    August 19, 1996
    Date of Event
    August 2, 1996
    Report Date
    August 13, 1996
    Manufacturer
    ALTON DEAN MEDICAL
    Product Code
    KZD
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PRESSURE IRRIGATOR DOOR CRACKED UNDER A REPORTED AIR PRESSURE OF ABOUT 550MM HG. A PIECE OF THE DOOR FULLY SEPARATED FROM THE COVER ALONG THE FULL LENGTH OF THE LATCH SIDE OF THE DOOR. THE PART THAT SEPARATED WAS UNDER THE LATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN SI-1000 PRESSURE IRRIGATOR KZD ALTON DEAN MEDICAL SI-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *